Achieving robust compliance using people and systems

Achieving robust compliance using people and systems

Quality-driven companies will make a conscious effort to continuously acquire, interpret and integrate regulatory re quirements and expectations into sustained performance.

By Richard Prince

The term “value-added” is heard a lot these days. I`ll jump on the bandwagon and coin a new phrase: Value-Added Compliance. (Apologies to anyone who may have already invented the term!) What should value-added compliance mean and how can it benefit the company that embraces it?

Assuming the culture of an organization is reflected in the firm`s management behavior, the only way to voluntarily obtain a robust state of compliance is to operate in an environment in which robust compliance is demanded by management. But, compliance to what? First, compliance to over-arching local, state, national and international regulatory requirements. Second, compliance to company policies and procedures. In a quality-driven, knowledge-based company, there will be a conscious effort to continuously acquire, interpret and integrate regulatory requirements and expectations into sustained company performance.


The capacity to robustly operate in accordance with current good manufacturing practices (cGMPs) requires, as mentioned, the continuous acquisition and proper interpretation of regulatory-oriented information, as well as the development and implementation of technology and systems which enable a firm to communicate and direct the desired manufacturing outcomes (i.e. practices) in a seamless manner. An example of a technology enabler is an intranet communications system. An example of a management-based enabler is the regular use of quality councils that are attended by the responsible leaders of the various functions, and which require timely changes or actions taken, as needed. An example of a business process-based enabler is the deployment of “process owners” or “process champions,” individuals who are empowered to effect the needed outcomes across functional boundaries (e.g. from research to manufacturing) to reduce the inherent risk associated with the product development process in structured organizational settings. The degree of compliance is logically an automatic offshoot of the soundness of the cross-functional systems in place and in use at a manufacturing facility.

In its clearest terms, the rudimentary aspects of (manufacturing) operations are spelled out in CFR 21, Part 210.1(a). The better the manufacturing system (process) in terms of its technology, validated status, procedures, training, change control and documentation, the better the compliance posture shall be upon critical systemic review. That said, there are a series of inputs and outputs that help compose various manufacturing sub-processes — apart from the standardized batch production process — that are worth discussing. The inputs and outputs must be procedurally defined in terms of what they are and what they are intended to directly accomplish.

An example of an input is one department notifying another department of a testing specification change. The “originating” department, for instance, is regulatory affairs and the “receiving” department is quality assurance. In this case, the owner of the change control system must be able to gain timely access to the new regulatory information, and then manage the change — communicate the specification change and its relative impact on product quality systems to all affected customers to permit the necessary system adjustments. With the change properly implemented, meaning personnel have been trained on the revised procedure, we have greater confidence that the firm will be able to comply with the new requirements. Unfortunately, some firms lack these types of basic product quality systems, or the management of these systems are weakly administered or enforced. For example, significant changes made to an existing process or procedure does not lead to mandatory re-training of affected personnel in a timely basis.

A client of mine now utilizes only one procedure (system) to govern the handling of all types of deviations within its plant. Previously there were multiple investigation-based procedures that alluded to various other investigation-based procedures, with each procedure having its own unique review date, etc. This arrangement was prone to creating procedural inconsistencies, as well as being deemed inefficient from a business perspective.

Systems thinking

Procedures that fully describe the underlying process or system possess twin virtues. First, it demonstrates to a potential critic that your systems and processes are comprehensively described. From an FDA perspective, documentation rigor is a cornerstone of good compliance management. Second, it enables personnel responsible for executing these procedures to have a clearer understanding of the interrelationships between the tasks. This fosters, in turn, a better appreciation for the importance of performing each respective task properly. For example, if a person who performs a growth promotion test is aware that a failing media result means that all other microbiological testing that has been performed with that batch of media is now invalid, that person will want to be doubly sure that he or she performs that particular task properly. The procedure should require this individual to immediately notify the supervisor in such an event. Detaching the consequences of failing growth promotion (media) results from the mechanics of the microbiological release tests represents an example of a lack of systems thinking in a procedure in this hypothetical example.

To paraphrase, the procedure, if it is truly systemic in kind, should possess the following attributes: 1) The underlying process is fully described; 2) Inputs and outputs, in other words the intra-departmental and interdepartmental transactions, are integrated into the process description; and 3) Responsible parties are identified throughout the process description.

The development and implementation of robust product quality systems, and the reflection of those systems in comprehensively written procedures which are properly administered by well-trained personnel will result in a compliant plant. Operating at a level of sustained compliance also represents a good business practice because costs are reduced owing to the reduction or elimination of recalls, regulatory actions, batch rejection, process deviations and the like. In the end, it is valued-added manufacturing that automatically begets, and is integral to, a robust state of compliance.CR

Richard Prince Ph.D., is president of Richard Prince Associates, Inc. (Short Hills, NJ), a pharmaceutical-based consultancy. Prince has been providing contract testing and, now, consulting services to the pharmaceutical and allied industries for 12 years. He has a bachelor of arts degree in microbiology from Rutgers University and a doctorate in zoology and physiology from Rutgers. He can be reached at (973) 564-8565 or E-mail: [email protected].


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